Ignite Creation Date:
2024-05-06 @ 7:33 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06059183
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-12
First Post:
2023-08-24
Brief Title:
The FAB Score Inter-rater Reliability Study
Sponsor:
Mid and South Essex NHS Foundation Trust
Organization:
Mid and South Essex NHS Foundation Trust
Study Overview
Official Title:
Investigating the Inter-rater Reliability of the Functional Assessment for Burns FAB Score in Adult Burn Inpatients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The Functional Assessment for Burns FAB score is an instrument developed by therapists at St Andrews Burns Centre Mid Essex Hospital Services NHS Trust where it is currently used as standard protocol to measure the physical functional recovery and independence of adult burn inpatients
The aim of this research is to test the ability of the FAB score to collect accurate data when used by three different therapists observing the same patient carrying out specific functional tasks ie inter-rater reliability
The aim of this research is to test the ability of the FAB score to collect accurate data when used by three different therapists observing the same patient carrying out specific functional tasks ie inter-rater reliability
Detailed Description:
Study purpose
Burn survivors face numerous physical challenges eg reduced range of motion upperlower limb impairments pain swelling and itching that affect activities of daily living eg feeding hygienic self-care dressing getting inout of bed walking and stair climbing Assessment of physical function and independence through valid and reliable instruments is essential during inpatient rehabilitation of adult burn survivors in order to optimise their physical recovery and determine likely discharge outcomes The FAB assessment is routinely carried out on patients at St Andrews Burns Centre and the predictive validity of the FAB score has previously been tested in adult burn patients however it has yet to be tested for inter-rater reliability Therefore the main purpose of this study is to investigate the ability of the FAB score to collect accurate data free from measurement error when used by multiple raters observing the same clinical episode
Study design
A quantitative reliability study will be carried out All patients admitted to adult inpatients at St Andrews Burn Centre will be screened and recruited according to inclusionexclusion criteria by the Chief Investigator There will be no change to patients routine care as it is standard protocol for patients admitted to the burns ward to receive a FAB assessment within 48h of admission FAB 1 and 48h of discharge FAB 2 with interim assessments performed as necessary to monitor patients progress and aid in maintaining motivation In order to avoid any risk of potentially causing patients distress from too many assessing therapists a maximum of three clinicians will be selected from a convenience sample of the burns inpatient therapy team n12 For each episode the most clinically senior of the three raters will conduct the FAB assessment Each rater will score the patient individually and will be blinded to the other observers results If a patient requires the assistance of more than one physiotherapistoccupational therapist to complete a task the clinician is permitted to report I am assistingsupervisingnot assisting but not state how this would be represented as a FAB score
Data analysis
Scores from each assessment episode will be imported into MedCalc statistical package Calculation of the Intraclass correlation coefficient ICC will assess the agreement and therefore the inter-rater reliability of the results provided by the three therapists both as individual FAB score components and as an overall functional outcome measure The ICC values range between 0 and 1 with values 070 considered good agreement Therefore the desired ICC for the study will be set at 070 and ICC values will be interpreted as follows 050 poor agreement 050-070 moderate agreement 070-090 good agreement 090 excellent agreement and 100 perfect agreement The statistical analysis of the ICC is obtained by analysis of variance ANOVA As there will be three different raters for each scoring episode a One-Way Random Effects Model will be used in a fully crossed study design A One-Way model will allow flexibility of rater selection depending on therapists availability as consistent participation on a busy hospital ward will not be achievable As this model will not be able to separate rater and total variance ie rater and error variances combined both error and rater variances must be small to achieve a desirable agreement level
Sample size
In order to determine a sample size for the ICC it is necessary to have the desired ICC value the expected confidence level and the confidence level associated with the confidence interval As ICC values 070 are considered good agreement the ICC will be set at 070 The expected confidence interval width is determined by a pre-specified power of at least 08 with 95 confidence interval The confidence level associated with the confidence interval is examined in graphical form with expected 95 confidence interval width plotted against the desired ICC value This reveals that for a sample size yielding a 95 confidence interval and confidence levels not exceeding 056 070 x 080 the study will require a minimum of 60 measurements FAB scores As three raters will be present for each assessment this will therefore require a minimum of 20 patient scoring episodes
The study design data analysis and sample size for this quantitative reliability study is based on a previous study investigating a different tool that uses a similar scoring method the Functional Assessment for Burns in Critical Care FAB-CC at St Andrews Burns Intensive Care Unit
Burn survivors face numerous physical challenges eg reduced range of motion upperlower limb impairments pain swelling and itching that affect activities of daily living eg feeding hygienic self-care dressing getting inout of bed walking and stair climbing Assessment of physical function and independence through valid and reliable instruments is essential during inpatient rehabilitation of adult burn survivors in order to optimise their physical recovery and determine likely discharge outcomes The FAB assessment is routinely carried out on patients at St Andrews Burns Centre and the predictive validity of the FAB score has previously been tested in adult burn patients however it has yet to be tested for inter-rater reliability Therefore the main purpose of this study is to investigate the ability of the FAB score to collect accurate data free from measurement error when used by multiple raters observing the same clinical episode
Study design
A quantitative reliability study will be carried out All patients admitted to adult inpatients at St Andrews Burn Centre will be screened and recruited according to inclusionexclusion criteria by the Chief Investigator There will be no change to patients routine care as it is standard protocol for patients admitted to the burns ward to receive a FAB assessment within 48h of admission FAB 1 and 48h of discharge FAB 2 with interim assessments performed as necessary to monitor patients progress and aid in maintaining motivation In order to avoid any risk of potentially causing patients distress from too many assessing therapists a maximum of three clinicians will be selected from a convenience sample of the burns inpatient therapy team n12 For each episode the most clinically senior of the three raters will conduct the FAB assessment Each rater will score the patient individually and will be blinded to the other observers results If a patient requires the assistance of more than one physiotherapistoccupational therapist to complete a task the clinician is permitted to report I am assistingsupervisingnot assisting but not state how this would be represented as a FAB score
Data analysis
Scores from each assessment episode will be imported into MedCalc statistical package Calculation of the Intraclass correlation coefficient ICC will assess the agreement and therefore the inter-rater reliability of the results provided by the three therapists both as individual FAB score components and as an overall functional outcome measure The ICC values range between 0 and 1 with values 070 considered good agreement Therefore the desired ICC for the study will be set at 070 and ICC values will be interpreted as follows 050 poor agreement 050-070 moderate agreement 070-090 good agreement 090 excellent agreement and 100 perfect agreement The statistical analysis of the ICC is obtained by analysis of variance ANOVA As there will be three different raters for each scoring episode a One-Way Random Effects Model will be used in a fully crossed study design A One-Way model will allow flexibility of rater selection depending on therapists availability as consistent participation on a busy hospital ward will not be achievable As this model will not be able to separate rater and total variance ie rater and error variances combined both error and rater variances must be small to achieve a desirable agreement level
Sample size
In order to determine a sample size for the ICC it is necessary to have the desired ICC value the expected confidence level and the confidence level associated with the confidence interval As ICC values 070 are considered good agreement the ICC will be set at 070 The expected confidence interval width is determined by a pre-specified power of at least 08 with 95 confidence interval The confidence level associated with the confidence interval is examined in graphical form with expected 95 confidence interval width plotted against the desired ICC value This reveals that for a sample size yielding a 95 confidence interval and confidence levels not exceeding 056 070 x 080 the study will require a minimum of 60 measurements FAB scores As three raters will be present for each assessment this will therefore require a minimum of 20 patient scoring episodes
The study design data analysis and sample size for this quantitative reliability study is based on a previous study investigating a different tool that uses a similar scoring method the Functional Assessment for Burns in Critical Care FAB-CC at St Andrews Burns Intensive Care Unit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None